Time Frame Analysis of Medical Device Approval, New Health Technology Assessment, and Reimbursement Decision-Making...

The time required for the health insurance listing, including health technology assessment (HTA) after medical device approval, has a significant impact on the medical device industry, clinical practice, and patient access to treatment. The aim of this study is to analyze the total time frame from device approval to health insurance listing via HTA and to examine the duration of each procedural step.

Using publicly available data, the study identified 34 medical technologies submitted for HTA and subsequently listed for health insurance coverage between 2021 and 2023. The study analyzed the time frame from device approval to health insurance listing, including evaluation periods for existing coverage category determination, HTA, and listing.

The median time from device approval to health insurance listing was 6.0 years for all technologies (n = 34) and 2.4 years for moderate- to high-risk or novel devices requiring pre-market approval (n = 15). For technologies that utilized the parallel review track (n = 8), the median time was 1.5 years. Median durations for existing coverage category determination, HTA, and health insurance listing for all technologies were 64.0, 244.5, and 346.0 days, respectively, and for moderate- to high-risk or novel devices, 65.0, 240.0, and 339.0 days, respectively.

The process from device approval to health insurance listing in Korea takes a considerable amount of time. Streamlining evaluation and reimbursement processes is essential to accelerating patient access to novel treatments. To support the timely adoption of new technologies, policymakers should prioritize efficiency while maintaining safety and effectiveness standards.